NCT05649566

Brief Summary

Prospective, controlled, randomized, non-masked longitudinal research project for the realization of a doctoral thesis, based on an intervention with virtual reality in order to assess whether the influence on balance and the oculomotor muscles is positive. The introduction of new technologies in the field of medicine in all fields, and in particular the rehabilitation is fully in place and under development. There are numerous examples like these technologies, including virtual reality (VR), have helped different health fields such as surgery or physiotherapy. The main aim of the study is to analyze these factors and analyze the way in which virtual reality (VR) can modulate the convergence of the gaze and can influence the center of pressure (COP). As secondary objectives es proposes to analyze the interrelationship between the VR and the COP to analyze the clinical possibilities of application in the field of rehabilitation, whether due to a downward (oculomotor) or upward alteration (COP alteration), as well as if physical activity or gender can also influence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

November 30, 2022

Last Update Submit

December 11, 2022

Conditions

Keywords

Postural BalanceOculomotor MusclesVirtual Reality

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Centre Of Pressure at 7 days after 12th session

    The pressure center (COP) is the point where the resulting reaction forces with the ground is applied to the support base. The oscillation of the individual with respect to the ground is projected in an anteroposterior line (AP) and a mediolateral line (ML). With these two parameters, the total route covered by the COP can be defined. An alteration of balance can be objectified by measuring an increase in the same area; reflecting a loss of control of the AP and ML axes and a slowdown in the perception of this loss.

    Day 1 and 7 days after the 12th session.

Secondary Outcomes (1)

  • Change from Baseline PPC at 7 days after 12th session

    Day 1 and 7 days after the 12th session.

Study Arms (2)

Virtual Reality Game Group

EXPERIMENTAL

A total of 24 interventions will be carried out for each participant, separated by 2 each week for 3 months. Each intervention will consist of a VR session lasting 30 minutes. Each participant must play for 30 minutes in the game "Beat know". The game consists of cutting mobile targets, using lightsabers while avoiding obstacles that approach the user. This game is a reference for immersive play since, while distracting, it recreates a physical activity similar to what would be done in reality. It has been shown that the same energy expenditure, on the part of the user, practicing tennis in real life, is what he does playing "Beat Saber" playing the same period of time.

Device: Virtual Reality game

Control Group

NO INTERVENTION

No intervention during 12 weeks.

Interventions

The game consists of cutting mobile targets, using lightsabers while avoiding obstacles that approach the user. This game is a reference for immersive play since, while distracting, it recreates a physical activity similar to what would be done in reality. It has been shown that the same energy expenditure, on the part of the user, practicing tennis in real life, is what he does playing "Beat Saber" playing the same period of time.

Also known as: Beat Saber on Oculus Quest 2 glasses
Virtual Reality Game Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 25 years old.
  • No visual alteration.
  • No history of vertigo.
  • No pathology that compromises balance.
  • Physically active (where the first two questions are affirmative and are 3 days and 3 hours, respectively.

You may not qualify if:

  • Taking medication that affects the nervous and/or motor system.
  • Smoking, alcoholism, taking illicit drugs or neurologically active medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escoles Universitaries Gimbernat

Sant Cugat del Vallès, Barcelona, 08174, Spain

Location

Related Publications (23)

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    BACKGROUND
  • León-Molina, P., et al., Center of plantar pressure and postural balance depending on the skull preposition. Rev Fac Odontol Univ Antioq 2016. 28(1): 112-122.

    BACKGROUND
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    PMID: 10811546BACKGROUND
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    PMID: 11733877BACKGROUND
  • Brandt T, Krafczyk S, Malsbenden I. Postural imbalance with head extension: improvement by training as a model for ataxia therapy. Ann N Y Acad Sci. 1981;374:636-49. doi: 10.1111/j.1749-6632.1981.tb30907.x.

    PMID: 6978651BACKGROUND
  • Jackson RT, Epstein CM. Effect of head extension on equilibrium in normal subjects. Ann Otol Rhinol Laryngol. 1991 Jan;100(1):63-7. doi: 10.1177/000348949110000110.

    PMID: 1985528BACKGROUND
  • Paulus WM, Straube A, Brandt T. Visual stabilization of posture. Physiological stimulus characteristics and clinical aspects. Brain. 1984 Dec;107 ( Pt 4):1143-63. doi: 10.1093/brain/107.4.1143.

    PMID: 6509312BACKGROUND
  • Pinsault N, Vuillerme N. Differential postural effects of plantar-flexor muscle fatigue under normal, altered and improved vestibular and neck somatosensory conditions. Exp Brain Res. 2008 Oct;191(1):99-107. doi: 10.1007/s00221-008-1500-z. Epub 2008 Jul 29.

    PMID: 18663436BACKGROUND
  • Blanchet M, Prince F, Messier J. Development of postural stability limits: Anteroposterior and mediolateral postural adjustment mechanisms do not follow the same maturation process. Hum Mov Sci. 2019 Feb;63:164-171. doi: 10.1016/j.humov.2018.11.016. Epub 2018 Dec 14.

    PMID: 30557794BACKGROUND
  • Whitney SL, Roche JL, Marchetti GF, Lin CC, Steed DP, Furman GR, Musolino MC, Redfern MS. A comparison of accelerometry and center of pressure measures during computerized dynamic posturography: a measure of balance. Gait Posture. 2011 Apr;33(4):594-9. doi: 10.1016/j.gaitpost.2011.01.015. Epub 2011 Feb 17.

    PMID: 21333541BACKGROUND
  • Winter, David A. Review Article: Human balance and posture control during standing and walking. Gait and posture, 1995. 3: p 193-214

    BACKGROUND
  • Chandler JM, Duncan PW, Studenski SA. Balance performance on the postural stress test: comparison of young adults, healthy elderly, and fallers. Phys Ther. 1990 Jul;70(7):410-5. doi: 10.1093/ptj/70.7.410.

    PMID: 2192373BACKGROUND
  • Sofianidis G, Dimitriou AM, Hatzitaki V. A Comparative Study of the Effects of Pilates and Latin Dance on Static and Dynamic Balance in Older Adults. J Aging Phys Act. 2017 Jul;25(3):412-419. doi: 10.1123/japa.2016-0164. Epub 2017 Jun 28.

    PMID: 27992251BACKGROUND
  • Mestre C, Bedell HE, Diaz-Douton F, Pujol J, Gautier J. Characteristics of saccades during the near point of convergence test. Vision Res. 2021 Oct;187:27-40. doi: 10.1016/j.visres.2021.06.001. Epub 2021 Jun 17.

    PMID: 34147850BACKGROUND
  • Erhardsson M, Alt Murphy M, Sunnerhagen KS. Commercial head-mounted display virtual reality for upper extremity rehabilitation in chronic stroke: a single-case design study. J Neuroeng Rehabil. 2020 Nov 23;17(1):154. doi: 10.1186/s12984-020-00788-x.

    PMID: 33228710BACKGROUND
  • Rutkowski S, Adamczyk M, Pastula A, Gos E, Luque-Moreno C, Rutkowska A. Training Using a Commercial Immersive Virtual Reality System on Hand-Eye Coordination and Reaction Time in Young Musicians: A Pilot Study. Int J Environ Res Public Health. 2021 Feb 1;18(3):1297. doi: 10.3390/ijerph18031297.

    PMID: 33535539BACKGROUND
  • Prasertsakul T, Kaimuk P, Chinjenpradit W, Limroongreungrat W, Charoensuk W. The effect of virtual reality-based balance training on motor learning and postural control in healthy adults: a randomized preliminary study. Biomed Eng Online. 2018 Sep 18;17(1):124. doi: 10.1186/s12938-018-0550-0.

    PMID: 30227884BACKGROUND
  • Hagstromer M, Oja P, Sjostrom M. The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr. 2006 Sep;9(6):755-62. doi: 10.1079/phn2005898.

    PMID: 16925881BACKGROUND
  • Minoonejad H, Barati AH, Naderifar H, Heidari B, Kazemi AS, Lashay A. Effect of four weeks of ocular-motor exercises on dynamic visual acuity and stability limit of female basketball players. Gait Posture. 2019 Sep;73:286-290. doi: 10.1016/j.gaitpost.2019.06.022. Epub 2019 Jul 16.

    PMID: 31398634BACKGROUND
  • Szpak A, Michalski SC, Loetscher T. Exergaming With Beat Saber: An Investigation of Virtual Reality Aftereffects. J Med Internet Res. 2020 Oct 23;22(10):e19840. doi: 10.2196/19840.

    PMID: 33095182BACKGROUND
  • Alsiri N, Cramp M, Barnett S, Palmer S. Gait biomechanics in joint hypermobility syndrome: a spatiotemporal, kinematic and kinetic analysis. Musculoskeletal Care. 2020 Sep;18(3):301-314. doi: 10.1002/msc.1461. Epub 2020 Feb 22.

    PMID: 32086882BACKGROUND
  • Lai B, Davis D, Narasaki-Jara M, Hopson B, Powell D, Gowey M, Rocque BG, Rimmer JH. Feasibility of a Commercially Available Virtual Reality System to Achieve Exercise Guidelines in Youth With Spina Bifida: Mixed Methods Case Study. JMIR Serious Games. 2020 Sep 3;8(3):e20667. doi: 10.2196/20667.

    PMID: 32880577BACKGROUND
  • Ernst N, Schatz P, Trbovich AM, Emami K, Eagle SR, Mucha A, Collins MW, Kontos AP. Utility of 1 Measurement Versus Multiple Measurements of Near Point of Convergence After Concussion. J Athl Train. 2020 Aug 1;55(8):850-855. doi: 10.4085/1062-6050-431-19.

    PMID: 32577736BACKGROUND

Study Officials

  • Sergio Gomez Doctor, PT, MsC

    E.U. Gimbernat

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: A clinical trial is proposed with young men and women between 18 and 25 years old and physically active (targeted with the International Physical Activity Questionnaire, IPAQ).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 14, 2022

Study Start

January 1, 2022

Primary Completion

June 30, 2022

Study Completion

September 30, 2022

Last Updated

December 14, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations